Doula Support for Postpartum Care of Preterm Children
(NEST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this research is to conduct a randomized clinical trial to examine the impact of nurse-coordinated, doula-delivered postpartum support (intervention arm) on postpartum health care utilization, health outcomes, and patient-reported experiences compared with standard postpartum care (control arm) among individuals with preterm births \<34 weeks' gestation requiring neonatal intensive care unit (NICU) admission.
Are You a Good Fit for This Trial?
This trial is for people who have given birth to a baby before 34 weeks of pregnancy and whose newborn needed care in the NICU. Participants are new mothers facing postpartum challenges, including mental health or anemia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive at least weekly doula support while their newborn(s)/infant(s) is/are admitted in the NICU, for a minimum of 3 visits. They also receive nurse-coordinated postpartum care, mental health screening and referral, and consistent follow-up for iron deficiency anemia.
Control
Participants receive routine postpartum care by their regular OB provider office.
Follow-up
Participants are monitored for postpartum depression, PTSD symptoms, and satisfaction with the program through questionnaires at 3 and 6 months postpartum.
What Are the Treatments Tested in This Trial?
Interventions
- Doula-delivered, Nurse-coordinated postpartum support
Trial Overview
The study compares extra postpartum support from doulas coordinated by nurses with standard care. Participants are randomly assigned to either receive this added support or usual care after giving birth.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive at least weekly doula support while their newborn(s)/ infant(s) is/are admitted in the NICU, for a minimum of 3 visits. Participants will have the option to receive routine postpartum care through their regular OB provider office or by the nurse associated with the study on NICU premises before going back to their regular OB provider. They will remotely fill a mental health questionnaire at 3 months and questionnaires at 6 months regarding mental health, breastfeeding practices, and satisfaction with the program.
Participants will receive routine postpartum care by their regular OB provider office and will fill remotely questionnaires at 6 months regarding mental health and breastfeeding practices.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Carolina
Lead Sponsor
Prisma Health-Midlands
Collaborator
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